MAUDE Adverse Event Report: ELEKTA LTD ELEKTA SYNERGY; ACCELERATOR, LINEAR, MEDICAL

Device Problems Computer Software Problem (1112); Unintended Movement (3026)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's preliminary investigation has confirmed that the inversion occurred during the use of cma and in the vertical axis only.A review of the mosaiq configuration has identified the table was not correctly configured.On the 26th may 2017 the characterisation of the system has since been updated by elekta.The table moves have been fully tested and the machine returned to clinical state following the updates.

Event Description

The customer reported that the table shift in the vertical direction was inverted (moved the opposite direction to that expected).Incident occurred on the (b)(6) 2017.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The results demonstrate the potential for incorrect characterization of couch values, which would lead to incorrect table movement when using couch move assistant (cma) feature in mosaiq.This is a result of the machine characterization (mac) file, which is instrumental to the correct operation of mosaiq and the elekta linac, being input incorrectly.An important field safety notice (371-01-msq-011) has been released from the 30-jun-2017, to all customers.This contains instructions for a verification tests customers must preform to ensure the mac file is correctly installed.The elekta recall reference for this action is fca-ims-0024.

• Brand Name: ELEKTA SYNERGY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA LTD; linac house; fleming way; crawley, west sussex RH10 9RR; UK RH10 9RR
• Manufacturer (Section G): ELEKTA LTD; linac house; fleming way; crawley, RH10 9RR; UK RH10 9RR
• Manufacturer Contact: pms pms ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 6645995
• MDR Text Key: 77832071
• Report Number: 9617016-2017-00024
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K05193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1